The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-100
SponsorDemocritus University of Thrace

About this trial

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in the elderly worldwide. The dry, non-exudative form of the disease, although more common, is associated with gradual and significant decline in functional vision. Despite advancements in diagnostic and therapeutic approaches, a targeted intervention that improves the daily functionality of these patients is still lacking. One critical, yet often overlooked, factor that affects daily performance is lighting conditions.

This study aims to objectively assess the impact of different lighting intensity levels on patients with advanced dry AMD during the execution of everyday activities. A total of 60 individuals will be evaluated (30 healthy controls over 60 years of age and 30 patients with clinically diagnosed advanced AMD, according to NICE and AREDS criteria). Participants will undergo ophthalmological assessment (visual acuity, contrast sensitivity, OCT/OCTA, autofluorescence), and their performance on five functional tasks (mobility, object grasping, sit-to-stand transition, obstacle avoidance, and hanging clothes) will be evaluated under eight lighting levels (20-300 lux) at a constant color temperature (4000K), in a specially designed laboratory equipped with motion and eye-tracking systems.

The primary endpoint is overall performance, based on task completion time and errors, expressed on a custom performance scale (0-100). Secondary data include changes in pupil size as an indicator of visual adaptation. The study aims to determine the optimal lighting range that maximizes functional vision and improves the quality of life for patients with AMD.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy controls over the age of 60.

Diagnosis of bilateral dry age-related macular degeneration (AMD).

Disqualifiers

Patients with other ocular conditions such as high myopia, glaucoma, clinically significant diabetic retinopathy, and other diseases that may confound the evaluation of ocular outcome measurements.

Patients who have undergone intraocular surgeries, except for uncomplicated cataract extraction surgery performed at least 3 months prior to their inclusion in the study.

Individuals with systemic diseases, including oxalate kidney stones, Wilson's disease, hemochromatosis, lung cancer, or other illnesses associated with poor five-year survival.

Patients with binocular best-corrected distance visual acuity less than or equal to hand motion perception.

Trial population

* Healthy controls over the age of 60 * Patients with bilateral diagnosed advanced AMD (according to the UK's National Institute for Health and Care Excellence-NICE-or AREDS 9-step classification \[13\]), fulfilling at least one of the following criteria: i) Geographic atrophy of the macula ii) Best-corrected visual acuity in the affected eye \<6/18 or logMAR \>0.4 with dense/confluent drusen, advanced RPE changes, or vitelliform lesions iii) Fibrous scar iv) RPE tear v) Atrophy (absence/thinning of RPE and/or retina) vi) Cystoid degeneration (persistent intraretinal fluid or tubular structures unresponsive to therapy)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Distant Visual Acuity

    Diagnostic test

    Distant Visual acuity of all participants using DDART web-application monocularly in both eyes.

  • Optical Coherence Tomography

    Diagnostic test

    Optical Coherence Tomography of the macula will be performed to all patients.

  • Optical Coherence Tomography Angiography

    Diagnostic test

    Optical Coherence Tomography Angiography of the macula will be performed to all patients.

  • Autofluorescence imaging

    Diagnostic test

    Autofluorescence imaging using fundus camera for AMD staging.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Control Group3 interventions
Group B: AMD Patients4 interventions

Trial outcomes

Primary outcomes

1

ADL score

Each participant's activity score will be calculated based on task completion time and errors. Errors will incur time penalties. A total completion time will be derived for each activity under each lighting condition. A custom scoring scale from 0 (lowest) to 100 (highest) will be developed. Each participant's performance score will be generated from this scale, determining the optimal lighting condition for AMD patients.

Time frame
On the same day as clinical evaluation, approximately 2-4 hours following baseline assessments.

Secondary outcomes

1

Pupil Size

The behavior of patients' pupil sizes under different lighting conditions will be assessed to correlate pupil response with light intensity.

Time frame
On the same day as clinical evaluation, approximately 2-4 hours following baseline assessments.

Other outcomes

Sponsors and contacts

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